Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method

NCT ID: NCT04429620

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-30

Study Completion Date

2020-12-31

Brief Summary

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Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method

Detailed Description

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Sample preparation, serum separation by centrifugation

* 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.
* 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope

Conditions

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Sars-CoV2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Positive group

Subjects are diagnosed with SARS-CoV2 by qPCR assay.

Immunfluorescence

Intervention Type DIAGNOSTIC_TEST

Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.

Negative group

Subject were 2 times proved negative SARS-CoV2 by qPCR assay.

Immunfluorescence

Intervention Type DIAGNOSTIC_TEST

Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.

Interventions

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Immunfluorescence

Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Person over 18 years of age
* Signing a package leaflet and a informal consent
* In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.
* In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual

Exclusion Criteria

* Refuses to sign the consent form
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bilogical Research Centre, Szeged

UNKNOWN

Sponsor Role collaborator

Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katalin Burián, MD

Role: PRINCIPAL_INVESTIGATOR

University of Szeged, Institute of Clinical Microbilogy

Locations

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University of Szeged, Albert Szent-Györgyi Health Center

Szeged, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Katalin Burián, MD

Role: CONTACT

+36 62 544 000

Dávid Pintér, Pharm. D.

Role: CONTACT

Facility Contacts

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Katalin Burián, MD

Role: primary

+36 62 544 000

Related Links

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https://www.medrxiv.org/content/10.1101/2020.03.17.20037713v1.full.pdf

A serological assay to detect SARS-CoV-2 seroconversion in humans

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.11.2000266

Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020

Other Identifiers

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SARS-CoV-2-IIF-002

Identifier Type: -

Identifier Source: org_study_id

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